Suprachoroidal CLS-TA With Intravitreal Aflibercept Versus Aflibercept Alone in Subject With Diabetic Macular Edema

NCT03126786 | Completed Phase 2 Results FDA Drug

• 1 other identifier: CLS1004-201
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 29

Brief Summary

The purpose of this trial is to evaluate the safety and efficacy of suprachoroidal CLS-TA used with intravitreal aflibercept in subjects with DME.

Conditions

Diabetic Macular Edema

Keywords

Diabetes Mellitus; Diabetic Retinopathy; Microneedle; Mircoinjection; Triamcinolone; Choroid; Choroid Injection; Aflibercept; Suprachoroidal; Triamcinolone acetonide

Outcome Measures

Primary Outcomes (1)

• Mean Change From Baseline in Best Corrected Visual Acuity Letter Score

  Best corrected visual acuity (BCVA) refers to the measurement of the best possible vision that can be achieved following refraction or correction. BCVA was assessed following the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol and was measured in the number of letters read correctly on an ETDRS eye chart. An increase from the pre-treatment state in BCVA of 15 letters or more represents a clinically meaningful improvement.

  Baseline, 6 months

Secondary Outcomes (1)

• Mean Change From Baseline in Central Subfield Thickness

  Baseline, 6 months

Study Arms (2)

Active

ACTIVE COMPARATOR

Treatment will consist of IVT injection of Aflibercept followed by an SC injection of CLS-TA

Drug: IVT aflibercept; Drug: SC CLS-TA

Control

SHAM COMPARATOR

Treatment will consist of IVT aflibercept injection followed by a sham SC procedure

Drug: IVT aflibercept; Drug: Sham SC

Interventions

IVT aflibercept DRUG

IVT aflibercept \[2 mg/0.05 mL\]

Also known as: Eylea

Active; Control

Sham SC DRUG

sham SC

Also known as: suprachoroidal sham

Control

SC CLS-TA DRUG

CLS-TA \[4 mg/100 μL\] SC injection

Also known as: Triamcinolone Acetonide

Active

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis of type 1 or type 2 DM
• DME with central involvement (\> 300 µm in the central subfield on spectral-domain optical coherence tomography \[SD-OCT\], in the study eye
• ETDRS BCVA score of ≥ 20 letters read and ≤ 70 letters read in the study eye
• Naïve to local pharmacologic treatment for DME in the study eye

You may not qualify if:

• IOP \> 21 mmHg in the study eye at Visit 1 (Day -30 to -1); subjects are not excluded if IOP is \<22 mmHg in the study eye with no more than 1 IOP lowering medication
• Any previous treatment in the study eye with an ocular corticosteroid implant
• Has significant media opacity precluding evaluation of retina and vitreous in the study eye.
• History of glaucoma or optic nerve head change consistent with glaucoma damage
• History of glaucoma surgery
• History of clinically significant IOP elevation in response to corticosteroid treatment ("steroid responder")

Sponsors & Collaborators

• Clearside Biomedical, Inc.: lead

Study Sites (29)

Retinal Consultants of Arizona and Retinal Research Institute

Phoenix, Arizona, 85014-2709, United States

Location

Retina Centers, PC

Tucson, Arizona, 85704, United States

Location

California Retina Consultants

Bakersfield, California, 93309, United States

Location

Retina Vitreous Medical Group Clinical Research

Beverly Hills, California, 90211-1841, United States

Location

Northern California Retina Vitreous Associates Medical Group, Inc.

Mountain View, California, 94040, United States

Location

Retina Institute of California

Palm Desert, California, 92260, United States

Location

Retina Consultants San Diego

Poway, California, 92064-2526, United States

Location

MedEye Associates

Miami, Florida, 33143-5188, United States

Location

Retina Specialty Institute

Pensacola, Florida, 32503, United States

Location

Sarasota Retina Institute

Sarasota, Florida, 34239, United States

Location

Center for Retina and Macular Disease

Winter Haven, Florida, 33880, United States

Location

Emory Eye Center

Augusta, Georgia, 30909-6440, United States

Location

Marietta Eye Clinic

Marietta, Georgia, 30060, United States

Location

Midwest Eye Institute

Indianapolis, Indiana, 46290, United States

Location

Retina and Vitrous Associates of Kentucky

Lexington, Kentucky, 40509, United States

Location

The Johns Hopkins Wilmer Eye Institute

Baltimore, Maryland, 21287, United States

Location

Cumberland Valley Retina Consultants

Hagerstown, Maryland, 21740-5940, United States

Location

Retina Associates of NJ

Teaneck, New Jersey, 07666, United States

Location

Western Carolina Retinal Associates

Asheville, North Carolina, 28803, United States

Location

Oregon Retina Institute

Medford, Oregon, 97504, United States

Location

Black Hills Regional Eye Institute

Rapid City, South Dakota, 57701-7374, United States

Location

Retina Research Institute of Texas

Abilene, Texas, 79606-1224, United States

Location

Texas Retina Associates-Arlington

Arlington, Texas, 76012-2505, United States

Location

Austin Retina Associates

Austin, Texas, 78705, United States

Location

Texas Retina Associates

Dallas, Texas, 75231, United States

Location

Valley Retina Institute, P.A.

McAllen, Texas, 78503, United States

Location

Valley Retina Institute

McAllen, Texas, 78503, United States

Location

Medical Center Ophthalmology Associates

San Antonio, Texas, 78240-1502, United States

Location

Retina Consultants of Houston

The Woodlands, Texas, 77384, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus; Diabetic Retinopathy

Interventions

aflibercept; Triamcinolone Acetonide

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Retinal Diseases; Eye Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Diabetes Complications

Intervention Hierarchy (Ancestors)

Triamcinolone; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Results Point of Contact

• Title: Thomas Ciulla, MD MBA
• Organization: Clearside Biomedical, Inc.

thomas.ciulla@clearsidebio.com

(678) 392-2318

Study Officials

• Thomas Ciulla, MD

  Clearside Biomedical

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 20, 2017
• First Posted: April 24, 2017
• Study Start: July 11, 2017
• Primary Completion: April 17, 2018
• Study Completion: April 17, 2018
• Last Updated: May 13, 2021
• Results First Posted: May 13, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (29)